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Users of Copaxone aren't likely to be very happy about this article done by Italian researchers. These docs have been involved in MS research for a long time and have a good reputation in this area.

Harry

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Glatiramer Acetate Provides No Significant Effect in the Treatment of Multiple Sclerosis

Research News from The Cochrane Library

MILAN, Italy, May 27 /PRNewswire/ -- One of the currently most widely
prescribed treatments for multiple sclerosis (MS), glatiramer acetate
(Copaxone(R), Teva / Aventis), may provide no significant benefit on the main
outcomes measures in the disease, namely either slowing the progression of MS
or substantially affecting the risk of clinical relapses over time. "At
present there is insufficient evidence to support future routine use of
glatiramer acetate in clinical practice and more data from randomised clinical
trials are needed," said Dr Munari, neurologist and member of the Cochrane MS
Review Group.
The review, carried out by members of the Cochrane MS Group, incorporated
the results of 646 patients with MS who participated in four randomized,
placebo-controlled clinical trials. The review included both patients with
relapsing-remitting MS and chronic progressive MS (CPMS).
Glatiramer acetate is a random mixture of polypeptides derived from the
synthesis of four amino acids. It has structural properties similar to myelin,
the basic protein within the sheaths surrounding nerves. Its mechanism of
action is actually unknown, as it is for beta-interferons. It is prescribed
as a secondary alternative to beta interferon, which is well established in
the treatment of MS, a chronic disease of the nervous system that affects
young and middle-aged adults and can lead to permanent disability.
Currently available data do not provide definite evidence that glatiramer
acetate shows any significant effect on disease progression, measured as a
sustained worsening in the Expanded Disability Status Scale (EDSS). No
benefit was shown in CPMS patients (progression at two years: RR=0.69, 95% CI
[0.33 to 1.46]).
The most common systemic adverse events of glatiramer acetate were a
transient and self-limiting patterned reaction of flushing, chest tightness,
sweating, palpitations, and anxiety (relative risk = 3.40 (95% CI [2.22 to
5.21], p <0.00001]). Local injection-site reactions were observed in up to a
half of the patients treated with glatiramer acetate, thus making a blind
assessment of outcomes questionable.
"The trials in this review tended to focus on the effect of glatiramer on
the rate of relapses, whereas the outcome that people with MS are particularly
concerned about is the progression of their disease," said Dr. Filippini, Co-
ordinating Editor of the MS Review Group. "The absence of clinical benefit
with glatiramer reinforces the need for further research looking at clinically
significant outcomes and reliable measures such as patient disability over
time and quality of life."

Notes to Editors

Munari L, Lovati R, Boiko A. Therapy with glatiramer acetate for multiple
sclerosis (Cochrane Review). In: The Cochrane Library, Issue 1, 2004.
Chichester: Wiley.

Systematic Reviews bring together research on the effects of health care
and are considered the gold standard for determining the relative
effectiveness of different interventions. The Cochrane Collaboration is the
world's leading producer of these reviews.
The Cochrane Collaboration started in 1992. It is an international
organization with bases and participants throughout the world. The Cochrane
Collaboration (http://www.cochrane.org) aims to help people make well-informed
decisions about healthcare by preparing, maintaining and promoting the
accessibility of up-to-date systematic reviews of the effects of healthcare
interventions. It is a not-for-profit organization, established as a company,
limited by guarantee, and registered as a charity. It serves the information
needs of physicians, clinical researchers, nurses, midwives, dentists,
patients and healthcare policymakers at medical institutions, universities,
corporations, and healthcare organizations around the world,. The
Collaboration encompasses an established network of 50 research groups
worldwide that prepare and maintain Cochrane reviews, covering a range of
medical specialties. Approximately 10,000 people are actively involved in the
work of The Cochrane Collaboration, almost all on a voluntary basis.

The url address by which the Library can be accessed is
http://www.nicsl.com.au/cochrane/index.asp.


SOURCE Dr Luca M. Munari, M.D.
Web Site: http://www.nicsl.com.au/cochrane/index.asp
http://www.cochrane.org


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Yeah, that doesn't look great. I do know it's helping my psoriasis, though. A large patch showed up on my right elbow a little before my first major flare-up (and subsequent diagnosis). It's been there ever since and has not responded to anything I've done. I started on Copaxone last year, and now the patch is almost completely gone. This is after almost five years of no change.

My guess is that MS may not be from one simple cause, so lumping everyone together may skew trial results. Each drug may not work the same way for everyone. I also think that the psoriasis and the MS are linked, being both immune related diseases. I'm going to stick with Copaxone for now, until more data comes out on this (or a more effective drug emerges). I feel like I'm just guessing at this point anyway, so I may as well go with what seems to be the most promising.

I feel like I'm just guessing at this point anyway, so I may as well go with what seems to be the most promising.

Isn't that the truth with MS meds these days! It's trial and error and after you start on a drug, hold your breath that it might do something positive for you.

Read about Antegren, the new promising drug on the block, and one lady who was part of the trials said that her doc told her that some patients stop breathing after receiving the drug!!! The doc won't prescribe it now when it may become available later this year.

Harry

HarryZ wrote:Read about Antegren, the new promising drug on the block, and one lady who was part of the trials said that her doc told her that some patients stop breathing after receiving the drug!!!

Yeah. I heard that some people go into analeptic shock using it, so you have to be monitored every time you take it.

Copaxone seems to help with spasticity in my legs, but that's also easily effected by stress, so it might all be a mind game. I guess I don't mind the reason, as long as it helps.

The testimony of the unnamed doctor of an unnamed "lady" notwithstanding, I will wait for the Phase III trial results on Antegren and remain optimistic.

rndlph wrote:The testimony of the unnamed doctor of an unnamed "lady" notwithstanding, I will wait for the Phase III trial results on Antegren and remain optimistic.

Here is the message, word for word, taken from the MS Foundation in Florida's website:

"I have talked to my neuro about Antegren, as he is involved in some of the studies. He isn't that thrilled with it, because some patients stop breathing after taking it. It has to be administered in a hospital and not a dr's office due to the breathing problems that may result. It's not a huge percentage of people who stop breathing, but my dr said the % is high enough that he wouldn't recommend it to his patients.
He also told me that they didn't know if it would work if administered w/out a CRAB, and so at least for now, they are saying you have to be on one in addition to the Antegren for it to show any promise.

I hope they iron out the bugs and this proves to be a promising treatment. Just thought I'd share what my MS specialist had to say about it.

Teri"

____________


The Phase III trials of Antegren in Ireland were terminated early because Elan and Biogen stated that the results were so good they wanted to apply for FDA status about a year earlier than planned. They did not want to publish the results of these trials because as they said "we don't want to influence the Phase III trials that are going on in several other centres where the drug is being tested."

From what I have been told, some MS researchers were quite perturbed that Biogen and Elan took this route because the very nature of their press release about the early termination of the trial and subsequent FDA approval submission, will have an effect on the trials still being conducted.

I wonder what will happen if another trial centre publishes their results which are not anywhere near what they experienced in Ireland. I'm beginning to wonder if Biogen, the makers of Avonex, are far more interested in their bottom line as opposed to the health of the MS patient. Biogen's stock was going on a downward slide because Avonex was losing a big share of the MS drug market, mostly to Rebif. Since their announcement, the stock has been rising steadily.

Makes you wonder!

Harry